Food & Food Contact Materials
CIRS Group
Chemicals
Food
Cosmetic
Medical Devices
Agrochemicals
Biocides
Carbon Neutrality
Testing
Search

FDA Accepts Three Food Color Additive Petitions: Safflower Extract, Gardenia Blue, and Acetone

from CIRS by

On August 19, 2026, the U.S. Federal Register Vol. 91, No. 159 published notices announcing the acceptance of three food color additive petitions. At the same time, the WTO issued SPS notifications G/SPS/N/USA/3592, G/SPS/N/USA/3594, and G/SPS/N/USA/3595.

The three petitions concern safflower extract, gardenia (genipin) blue, and acetone as a processing solvent for carrot oil, respectively. All three applications are currently under technical review.

It should be noted that acceptance of a petition does not constitute approval for use. The substances may only be legally used in food in the United States after the complete review process has been completed and the relevant provisions of 21 CFR Part 73 have been amended.

Summary of the Key Contents of the Three Petitions

Petition Item

Docket No.

Submission Date

Key Request

Remarks

Safflower (Carthamus tinctorius L.) Extract

FDA-2026-C-8086

2026-07-20

Request for authorization as a color additive produced in accordance with GMP for use in 17 food categories, including baked goods, alcoholic beverages, prepared tea, confectionery, sweeteners, sauces, frozen dairy products, soups, and flavored syrups.

The petitioner has requested an exemption from the environmental assessment, and no public comment period is currently open.

Gardenia (Genipin) Blue

FDA-2026-C-8831

2026-08-04

1. Expand the permitted uses to 20 food categories, including sponge cakes, carbonated beverages, frozen tea, baked goods, fruit sauces, snack foods, chewing gum, etc.; 2. Tighten the arsenic impurity limit in the color additive from ≤2 mg/kg to ≤1 mg/kg.

The impurity specifications will be subject to stricter requirements, and stricter arsenic control of raw materials will be required going forward.

Acetone (Solvent for Carrot Oil Processing)

FDA-2026-C-8883

2026-08-03

Permit acetone to be used as a processing solvent for carrot oil; establish additional heavy metal control specifications for carrot oil and supplement the substance identification information.

An Environmental Assessment Report is included. The deadline for public comments is September 18, 2026.

Compliance Considerations

  1. The three petitions have only been accepted for review, and the current provisions of 21 CFR Part 73 have not yet been updated. Food companies exporting to the United States should not adopt any newly proposed uses or processing applications before final approval. Companies should continue to monitor the Federal Register for final approval notices issued by the FDA.
  2. Exporters currently using gardenia (genipin) blue should strengthen control over raw material impurities in advance. If the arsenic specification is formally tightened in the future, companies will need to update their raw material acceptance criteria accordingly.
  3. Regarding the petition concerning the use of acetone as a solvent in the processing of carrot oil, interested parties may submit electronic or written comments on the environmental assessment through Regulations.gov by September 18, 2026.

All petition documents and related materials can be searched and reviewed through the U.S. federal electronic docket system, Regulations.gov. Companies can use the platform to monitor the progress of the FDA’s review in real time.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

  

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

Contact Us
+353 1 477 3710 (EU)
+44 (0) 121 663 6785 (UK)
+1 703 520 1420 (USA)
+86 571 8720 6574 (CN)
+82 2 6347 8816 (KR)
+81 070-9365-8022 (JP)